FDA.reportPublic FDA data

PMA P040044S081

Device
MynxGrip Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S081
Product code
MGB
Decision date
2018-07-10
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Approval to add Steri-Tek (Smart World LLC) located at 48225 Lakeview Boulevard, Fremont, California 94538, as a new E-beam sterilization site for the MynxGrip Vascular Closure Device (5F/6F/7F).

Current openFDA PMA Record#

Device
MynxGrip Vascular Closure Device
Applicant
Cordis US Corporation
PMA number
P040044
Supplement
S081
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2018-07-10
Decision code
APPR
Date received
2018-05-16
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval to add Steri-Tek (Smart World LLC) located at 48225 Lakeview Boulevard, Fremont, California 94538, as a new E-beam sterilization site for the MynxGrip Vascular Closure Device (5F/6F/7F).